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MINILED ORTHO 2

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  • Page 1 User Manual MINILED ORTHO 2...
  • Page 2 This document is an English translation of the original French version. Reference J05220 version V3 and drawing number N005FR010C...
  • Page 3: Table Of Contents

    6.4.3 Performing a cure cycle 6.5 Switching off the medical device 6.6 Disconnecting the medical device 7 Medical device description 7.1 Screen of the medical device 7.2 Light indicator 7.3 MINILED ORTHO 2 7.4 Base 7.5 Operating mode 7.6 Buttons 7.7 Wave peak 7.8 Mains adapter 8 Disinfection and sterilising...
  • Page 4 10.6 Other malfunctions 11 Technical specifications of the medical device 11.1 Identification 11.2 Mains Adapter 11.3 Optical Guide 11.4 Handpiece 11.5 Battery 11.6 Base 11.7 Environmental characteristics 11.8 Environmental restrictions 11.9 Main performance characteristics 12 Regulations and standards 12.1 Applicable standards and regulations 12.2 Medical class of the device 12.3 Symbols 12.4 Manufacturer identification 12.5 Manufacturer responsibility...
  • Page 5: 1 Documentation

    Keep the original documentation for your medical device and its accessories for future reference. When loaning out or selling the medical device, the documentation must be provided with it. User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C - Page 3/38...
  • Page 6 Page 4/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 7: 2 Required Information

    2.3 Using accessories not supplied by the manufacturer The MINILED is designed to be used with SATELEC, a company of Acteon group accessories. The use of optical guides, protection shields or mains adapters made by other manufacturers will damage the MINILED.
  • Page 8 Page 6/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 9: 3 Unpacking The Medical Device

    Regularly wipe the power supply connector with a soft and dry cloth. After lengthy storage, charge and discharge the MINILED several times in order to achieve maximum performance. User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C - Page 7/38...
  • Page 10 Page 8/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 11: 4 Installing The Medical Device

    After its initial installation, the medical device is not designed to be moved. The medical device must be fixed to ensure that it cannot be removed or moved without the use of a tool. User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C - Page 9/38...
  • Page 12 Page 10/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 13: 5 Connect The Medical Device

    The MINILED operates with a Lithium-Ion battery. To guarantee optimum use, this battery must be fully charged before use but must never be flat. User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C - Page 11/38...
  • Page 14 It takes about 3 hours to charge the battery. Replace the MINILED on the charging base after each use for optimised battery efficiency. Page 12/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 15: 6 Dispensing A Treatment

    Remove the insulating ring located between the battery and the MINILED and screw the battery onto the handpiece. Place the MINILED on its charging base. The MINILED ORTHO 2 is correctly installed when two beeps are heard and the translucent support base lights up in blue and starts flashing. Leave the MINILED to fully charge.
  • Page 16: Connect The Accessories

    6.4.2.1 Selecting the exposure time Press the button to select the required exposure time: 4 seconds 8 seconds 12 seconds 32 seconds Available alarms Page 14/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 17: Performing A Cure Cycle

    Before a long absence or when not in use, the medical device must be cleaned, its battery must be removed and the charging base must be disconnected from the mains power. Page 15/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 18 Page 16/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 19: 7 Medical Device Description

    7 Medical device description 7.1 Screen of the medical device The MINILED ORTHO 2 has a backlit LCD screen which displays information about the device condition for the user: Four battery charge level indicators are shown to signal that the battery is fully charged.
  • Page 20: Wave Peak

    The mains cord connects the mains adapter to the medical device Only use the mains adapter supplied with your medical device. Page 18/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 21: 8 Disinfection And Sterilising

    The optical guide must be cleaned and sterilised prior to use. The rigid protection shield must be cleaned and disinfected prior to use. User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C - Page 19/38...
  • Page 22 Page 20/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 23: 9 Monitoring And Routine Maintenance

    The power tester may yield the following results: Colour Result Green The lamp is working correctly The lamp is not working correctly. Please read the chapter page 23 User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C - Page 21/38...
  • Page 24 Page 22/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 25: 10 Identifying Incorrect Operation

    Place the end of the optical guide at 2 mm from the cure site 10.5 Malfunction of the power tester Possible causes Solutions Defective light indicator Send the MINILED to Acteon's Customer Services team. User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C - Page 23/38...
  • Page 26: Other Malfunctions

    Keep the original packaging of the medical device and use it to return the device for servicing, maintenance or repair. Page 24/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 27: 11 Technical Specifications Of The Medical Device

    0 cm - 70 cm Estimated service life 10 years Length 120 mm without optical guide Diameter maximum outer 24 mm Weight 80 g User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C - Page 25/38...
  • Page 28: Battery

    Storage temperature 0°C to +50°C Storage RH 10% to 95%, including condensation Atmospheric storage pressure Between 500 hPa and 1060 hPa Page 26/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 29: Environmental Restrictions

    Wavelength between 420 nm and 480 nm, plus or minus 20 nm, depending on the batch of LEDs. Irradiance of 3,000 mW/cm , calculated on the active diameter of 4.8 mm with the opalescent optical guide. Page 27/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 30 Page 28/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 31: 12 Regulations And Standards

    Refer to the supporting documentation Consult the User Manual The accompanying documentation is available in electronic format Pressure limit Temperature limit User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C - Page 29/38...
  • Page 32 Ultrasonic bath Type B part in contact Direct current Direct current supply connector Electromagnetic interference CE marking Year of manufacture YYYY Page 30/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 33: Manufacturer Identification

    Non-compliance with the instructions contained in this document. Note: the manufacturer reserves the right to modify the medical device and any documentation without notice. Page 31/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 34: Branch Addresses

    Tel. +44 1480 477 307 Tel. +39 0331 376 760 Fax. +44 1480 477 381 Fax. +39 0331 376 763 info.uk@acteongroup.com info.it@acteongroup.com Page 32/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 35 ACTEON MIDDLE EAST 247 Wasfi Al Tal str. 401 AMMAN - JORDAN Tel. +962 6 553 4401 Fax. +962 6 553 7833 info.me@acteongroup.com Page 33/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 36: Disposal And Recycling

    When your medical device has reached the end of its service life, contact your nearest dental equipment dealer, or the Acteon head office or one of the company branches to find out how to proceed. The relevant contact details are given in the chapter Branch addresses page 32.
  • Page 37: 13 Index

    CE marking 5 gas-filled atmosphere 27 incorrect operation 23 light curing 5 mains adapter 18 Mains power 11 User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C - Page 35/38...
  • Page 38 Page 36/38 - User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C...
  • Page 39: 14 Glossary

    Is cleaned, disinfected and sterilised in an autoclave. User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C -Page 37/38...
  • Page 40 User Manual | MINILED ORTHO 2 | J05221 | V3 | (09) | 02/2022 | N005EN010C SATELEC A Company of the ACTEON Group 17 av. Gustave Eiffel ZI du Phare 33700 MERIGNAC FRANCE Tel. +33 (0) 556 34 06 07 Fax.

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